I've submitted my IRB application! What happens next?
The IRB Chair will review your proposal and evaluate its risk level. Every case is different, but in general the IRB Chair and IRB staff will contact you by email with our response. Zero to low-risk proposals generally get a response within one week, and moderate risk proposals usually take two weeks. High-risk proposals require full Board review, which only happens monthly during the academic calendar year. If the IRB Chair requests changes to your methods, documentation, or other items, you do not need to submit a new proposal—simply respond to the IRB email with answers to our questions, attaching updated documents as necessary.
If the IRB requests changes to my proposed research plan, do I need to submit a new proposal?
No, just respond to the emails you receive from the IRB Chair and IRB staff
How long does IRB approval take?
The approval process can take several weeks, depending on whether you meet the submission deadline, the complexity of your project, the subjects you intend to work with, the completeness of your application materials, and other factors. Plan to submit your application at least three weeks before you want to start your research.
Why does the College need to have an IRB?
Institutional Review Boards were a response to a disturbing series of terrible crimes committed against vulnerable populations in the name of scientific investigation, particularly in the 20th century. The most notorious examples are the Nazi experiments that came to light in the Nuremberg Trials, and one product of those post-war investigations was a code of professional behavior (The Nuremberg Code) that remains foundational to the ethics of research on human beings.
Equally disturbing cases in the U.S. (e.g., The Tuskegee Syphilis Experiments) led the federal government in the early 1970s to develop standards for proper treatment of human research subjects, and to require research institutions to comply with those standards. Establishing an IRB to oversee ethical compliance is one of those requirements. IRBs remain important as additional sets of eyes to evaluate research plans for safety and protection of rights, concerns that can be overlooked in a researcher's enthusiasm for his or her work.
Am I doing research on human subjects?
Please see Must I apply? if your research involves interaction with other human beings or working with restricted data sets about human subjects. But if you still are uncertain about whether it meets the definitions on this page, please contact the IRB! A quick email may be all it takes to determine whether or not you need to seek IRB approval.
I don’t plan to ignore my research subjects’ untreated syphilis or to do experimental lobotomies on mentally ill patients. Why do I need IRB approval?
The IRB is meant to protect human subjects from all kinds of potential harm, not just physical. Most research at Middlebury College won't expose subjects to the kinds of harm notorious in those infamous historical cases. But many of our research agendas might expose subjects to psychological, emotional, or (occasionally) physical risks about which they ought to be informed and to which they normally ought to be able to consent.
What do I have to do to get IRB approval of my research?
Fill out the IRB's application form, describing what you intend to do, the subject pool you intend to work with, and the measures you intend to employ to obtain informed consent and protect subjects' privacy. You'll also need to take an online course on the ethics of research on human beings. This course takes roughly three hours to complete. After you take the tutorial and pass the quiz, the site will provide a certificate of completion for you. Please save this form as a PDF, JPEG, or GIF and submit it with your protocol.
How do I get blanket IRB approval for the course I am teaching?
Courses in which the curriculum consists substantially of independent student research are subject to IRB approval. Faculty members seeking approval for a course must submit an application for the course.
What is the deadline for submitting my application?
Why haven’t I ever heard of the IRB before?
Traditionally IRBs dealt with research in the "hard" sciences and some social sciences, because other disciplines rarely involved human subjects in their research. That's changing, however, and human subjects—and therefore IRBs—are more frequently a part of research in the humanities. One recent example of the expansion of IRB concerns at Middlebury College beyond the hard sciences: a couple of years ago, a senior English major developed a research project on Dr. Seuss books, and in the process wanted to read one of his books to elementary school children and gauge their reactions. In this case, though, the Dr. Seuss book happened to be about nuclear holocaust, and the IRB was concerned enough about the emotional effect on the children that it required parental permission for the researcher to work with the elementary school class.
Where can I find more information?
My project was approved! Now what?
As Principal Investigator, you have a few ongoing responsibilities to the IRB. You must:
- notify the IRB if you want to change your research methods or location during the one-year approval period
- apply for an extension if you need a bit more time than one calendar year to complete your project
- apply for renewal if your project will run for another year
- submit a status report for your project to date if you want to renew or extend a project beyond the one-year approval period
- keep all documentation related to the project, including signed consent forms, for at least four years from the approval date (if you are a student, arrange this with your advisor)
- keep any publications resulting from your research for at least four years from the approval date (if you are a student, arrange this with your advisor)